Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support

ABSTRACT

Methods and systems for endovascular, endocardiac, or endoluminal approaches to a patient&#39;s heart to perform surgical procedures that may be performed or used without requiring extracorporeal cardiopulmonary bypass. Furthermore, these procedures can be performed through a relatively small number of small incisions. These procedures may illustratively include heart valve implantation, heart valve repair, resection of a diseased heart valve, replacement of a heart valve, repair of a ventricular aneurysm, repair of an arrhythmia, repair of an aortic dissection, etc. Such minimally invasive procedures are preferably performed transapically (i.e., through the heart muscle at its left or right ventricular apex).

This application claims the benefit of U.S. provisional patentapplication No. 60/615,009, filed Oct. 2, 2004, which is herebyincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

This invention relates generally to devices and methods for performingcardiovascular procedures wherein a heart valve or segment of the aortais being repaired or replaced without the use of extracorporealcardiopulmonary support (commonly referred to as “off-pump” procedures).For example, the invention relates to devices and methods for accessing,resecting, repairing, and/or replacing one of the heart valves, inparticular the aortic valve. This invention also relates to methods andsystems for performing minimally-invasive cardiac procedures such as theendovascular, endocardiac or endoluminal placement, implantation orremoval and consecutive replacement of heart valves. These techniquesmay be generally referred to as direct access percutaneous valvereplacement (“DAPVR”).

BACKGROUND OF THE INVENTION

Of particular interest to the present invention is the treatment ofheart valve disease. There are two major categories of heart valvedisease: (i) stenosis, which is an obstruction to forward blood flowcaused by a heart valve, and (ii) regurgitation, which is the retrogradeleakage of blood through a heart valve. Stenosis often results fromcalcification of a heart valve that makes the valve stiffer and lessable to open fully. Therefore, blood must be pumped through a smalleropening. Regurgitation can be caused by the insufficiency of any of thevalve leaflets such that the valve does not fully close.

In the past, repairing or replacing a malfunctioning heart valve withina patient has been achieved with a major open-heart surgical procedure,requiring general anesthesia and full cardiopulmonary by-pass. Thisrequires complete cessation of cardiopulmonary activity. While the useof extracorporeal cardiopulmonary by-pass for cardiac support is a wellaccepted procedure, such use has often involved invasive surgicalprocedures (e.g., median sternotomies, or less commonly, thoracotomies).These operations usually require one to two weeks of hospitalization andseveral months of rehabilitation time for the patient. The averagemortality rate with this type of procedure is about five to six percent,and the complication rate is substantially higher.

Endovascular surgical techniques for heart surgery have been underrecent development. In contrast to open-heart surgical procedures,endovascular procedures may have a reduced mortality rate, may requireonly local anesthesia, and may necessitate only a few days ofhospitalization. However, the range of procedures that has beendeveloped for an endovascular approach to date has been limited torepair of the coronary arteries, such as angioplasty and atherectomy.

Some progress has been made in the development of endovascular heartvalve procedures. For example, for patients with severe stenotic valvedisease who are too compromised to tolerate open-heart surgery toreplace the heart valve as described above, surgeons have attemptedendovascular balloon aortic or mitral valvuloplasty. These proceduresinvolve endovascularly advancing a balloon dilatation catheter into thepatient's vasculature until the balloon of the catheter is positionedbetween the valve leaflets. Then the balloon is inflated to either: (i)split the commissures in a diseased valve with commissural fusion, or(ii) crack calcific plaques in a calcified stenotic valve. However, thismethod may only provide partial and temporary relief for a patient witha stenotic valve. Instances of restenosis and mortality followingballoon aortic valvuloplasty have led to virtual abandonment of thisprocedure as a treatment for a diseased aortic valve.

Endovascular procedures for valve implantation inside a native anddiseased valve have been explored. A catheter-mounted valve isincorporated into a collapsible cylindrical structure, such as a stent(commonly referred to as a “valved stent”). In these procedures, anelongated catheter is used to insert a mechanical valve into the lumenof the aorta via entry through a distal artery (e.g., the femoral orbrachial artery). Such procedures have been attempted on selective,terminally ill patients as a means of temporarily relieving the symptomsof a diseased valve.

The percutaneous placement of an artificial valve may have certainlimitations and ancillary effects. For example, at present, suchprocedures are only of benefit to a small number of patients and are notmeant to become an alternative to surgical heart valve proceduresrequiring the use of extracorporeal bypass. Another issue is thatperforming the entire procedure via small diameter vessels (e.g., thefemoral, iliac or brachial arteries) restricts the use of larger toolsand devices for the resection or repair of the diseased heart valve.Furthermore, this endovascular procedure may increase the risk ofvarious vascular complications such as bleeding, dissection, rupture ofthe blood vessel, and ischemia to the extremity supplied by the vesselused to perform the operation:

Moreover, in some cases, one or more of a patient's femoral arteries,femoral veins, or other vessels for arterial and venous access may notbe available for introduction of delivery devices or valve removal toolsdue to inadequate vessel diameter, vessel stenosis, vascular injury, orother conditions. In such cases, there may not be sufficient arterialand venous access to permit the contemporaneous use of the necessaryinterventional devices (e.g., an angioplasty catheter, atherectomycatheter, or other device) for a single surgical procedure. Therefore,unless alternate arterial or venous access for one or more of thesecatheters can be found, the procedure cannot be performed usingendovascular techniques.

Another possible disadvantage of the small vessel procedure is that thenew valve must be collapsed to a very small diameter that could resultin structural damage to the new valve. Additionally, such remote accesssites like the femoral artery may make precise manipulation of thesurgical tools more difficult (e.g., exchange of guide wires andcatheters and deployment of the new valve). Furthermore, placing wires,catheters, procedural tools, or delivery devices through one or moreheart structures (e.g., the mitral valve) to reach the target site canresult in damage to those structures (e.g., acute malfunctioning orinsufficiency of the valve being mechanically hindered by the surgicalequipment or valve deterioration resulting from mechanical frictioninflicting micro-lesions on the valve).

Also to be considered in connection with such procedures is thepotential of obstructing the coronary ostia. The known percutaneousprocedures for implanting heart valves do not have a safety mechanism toensure proper orientation of the new valve. Therefore, there is apossibility that the deployed valve will obstruct the coronary ostia,which can result in myocardial ischemia, myocardial infarction, andeventually the patient's death.

These procedures leave the old valve in place, and the new valve isimplanted within the diseased valve after the diseased valve has beencompressed by a balloon or other mechanical device. Therefore, there maybe a possibility of embolic stoke or embolic ischemia from valve orvascular wall debris that is liberated into the blood flow as thediseased valve is dilated and compressed. Furthermore, a rim of diseasedtissue (e.g., the compressed native valve) decreases the diameter andcross-sectional surface of the implanted valve, potentiallyunder-treating the patient and leading to only partial relief of hissymptoms.

It would therefore be desirable to develop systems and methods forsatisfactorily performing various cardiovascular procedures,particularly procedures for heart valve placement or removal andreplacement, which do not require the use of an extracorporeal bypass orinvasive surgical procedure, such as a sternotomy. It would be furtherdesirable to perform such procedures through very small incisions in thepatient (e.g., via several small thoracotomies). The devices and methodswill preferably facilitate the access, resection, repair, implantation,and/or replacement of the diseased cardiac structure (e.g., one or morediseased heart valves). The devices and methods should preferablyminimize the number of arterial and venous penetrations required duringthe closed-chest procedures, and desirably, should require no more thanone cardiac and one femoral arterial penetration. The present inventionsatisfies these and other needs.

The descriptive terms antegrade and retrograde mean in the direction ofblood flow and opposite the direction of blood flow, respectively, whenused herein in relation to the patient's vasculature. In the arterialsystem, antegrade refers to the downstream direction (i.e., the samedirection as the physiological blood flow), while retrograde refers tothe upstream direction (i.e., opposite the direction of thephysiological blood flow). The terms proximal and distal, when usedherein in relation to instruments used in the procedure, refer todirections closer to and farther away from the heart, respectively. Theterm replacement normally signifies removal of the diseased valve andimplantation of a new valve. However, a new valve may also be implanteddirectly over top of a diseased valve. An implantation procedure wouldbe the same as a replacement procedure without the removal of thediseased valve.

SUMMARY OF THE INVENTION

The present invention is directed to a method and system for anendovascular, endocardiac, or endoluminal approach to a patient's heartto perform an operation that does not require an extracorporealcardiopulmonary bypass circuit and that can be performed through alimited number of small incisions, thus eliminating the need for asternotomy. The invention contemplates, at least in its preferredembodiments, the possibility of effective aortic valve implantation,aortic valve repair, resection of the aortic valve and replacement ofthe aortic valve, all without necessitating extracorporealcardiopulmonary by-pass, a median sternotomy or other grossly thoracicincisions.

The present invention contemplates replacing any of the four valves ofthe heart via an antegrade approach through the wall of the appropriatechamber. Preferably, valves are implanted transapically (i.e., throughthe heart muscle at its left or right ventricular apex). However, inthis case, replacement of the mitral and tricuspid valves may beperformed via a retrograde approach, because accessing these valves viathe left or right ventricles requires approaching these valves againstthe flow of blood through the valve.

In accordance with the present invention, a surgeon may perform aminimally invasive operation on a patient that includes accessing thepatient's heart and installing an access device in a wall of the heartthat has means for preventing bleeding through the access device. A newheart valve may be implanted via the access device. In addition toimplanting a heart valve during such a procedure, the surgeon can alsoresect a diseased native heart valve. The surgeon may also repair anaortic dissection using such a procedure. The surgeon may also choose torepair a damaged heart valve using similar techniques. The access devicedescribed may be preferably installed in the ventricular apex of theheart.

Surgical methods in accordance with the present invention may alsoinclude resecting a diseased heart valve percutaneously, whileinstalling the new heart valve transapically. Alternatively, a surgeonmay resect a diseased valve transapically and implant a new valvepercutaneously. Additionally, both removal and implantation could beperformed transapically. The new heart valve is preferably implanted byradially expanding the heart valve. In some embodiments, the radialexpansion occurs in multiple stages that may be effectuated by amulti-stage balloon. The implantation device may include a mechanism topull the leaflets of a native valve downward while the new valve isinstalled within the native valve.

A device for resecting a diseased heart valve in accordance with thepresent invention may include a first set of annularly enlargeablecomponentry having a first longitudinal axis and a proximal cutting edgeand a second set of annularly enlargeable componentry having a secondlongitudinal axis and a distal cutting edge. The device resects thediseased heart valve when the first set of componentry is enlarged on adistal side of the diseased heart valve and the second set ofcomponentry is enlarged on a proximal side of the diseased heart valveand the sets of componentry are drawn axially together along thelongitudinal axes. The first and second sets of annularly enlargeablecomponentry may be coaxial.

In accordance with the present invention, blood flow through thesurgical devices placed in the patient (e.g., inside the patient'saorta) may be supplemented with artificial devices such as ventricularassist devices. The surgical site may be visualized with direct opticaltechnology. For example, transparent oxygen-carrying fluid may beinjected into a portion of the circulatory system of a patient, and anoptical device may be inserted into the transparent fluid to transmitimages of the surgical site. Using such techniques, all blood of apatient's circulatory system may be temporarily exchanged with thetransparent oxygen-carrying fluid.

Instrumentation for accessing a chamber of a patient's heart may includea catheter having a proximal sealing device for sealing the catheteragainst a proximal surface of the myocardium. The instrumentation mayalso include means for preventing bleeding through the catheter. In someembodiments, the instrumentation includes a distal sealing device forsealing the catheter against the distal surface of the myocardium.

In accordance with the present invention, an implantable heart valve mayinclude a tissue support structure and tissue valve leaflets that aregrown inside the tissue support structure by genetic engineering. Thegenetically engineered leaflets may grow inside a stainless steel stent,a nitinol stent, or any other suitable tissue support structure.Low-profile heart valves may also be used that include at least threeleaflets. One side of each leaflet overlaps a neighboring leaflet suchthat the leaflets open sequentially and close sequentially. Replacementheart valves may also be used that correct overly-dilated heart valveannuluses. Such a heart valve may include an inner circumference definedby the leaflets of the heart valve and an outer circumference defined bythe outer limits of a fluid-tight diaphragm. The diaphragm fills thespace between the inner circumference and the outer circumference.

Surgeons may be aided by a device for inserting more than one guidewireinto a patient. Such a device includes an annular wire placement deviceand one or more guidewires removably attached to the annular wireplacement device. The annular wire placement device is configured totrack an already placed guidewire.

In accordance with the present invention, calcification of a heart valvemay be broken down by inserting a catheter-based ultrasound device intoa calcified heart valve and concentrating ultrasound radiation on thecalcification of the calcified heart valve to break down thecalcification. Such a procedure may be enhanced by inserting a reflectorinto the calcified heart valve to magnify the ultrasound radiation.

A mitral valve repair device in accordance with the present inventionmay include a first head defining an operating plane and a second headoperably attached to the first head. The second head is configured todisplace a leaflet with respect to the operating plane. The first headmay be U-shaped and include an attachment mechanism for attaching atleast two portions of a mitral valve leaflet. The repair device includesa handle for operating the second head with respect to the first head.

In accordance with the present invention, aortic dissections may berepaired by accessing a patient's heart and placing an access device ina wall of the heart that prevents bleeding through the access device. Adissection repair device is inserted through the access device to repairthe aortic dissection. The device may include annularly enlargeablecomponentry configured to be inserted into the patient's aorta and meansfor closing a void created by the aortic dissection. The void can beclosed by injecting a biologically compatible glue (e.g., fibrin,thrombin, or any other suitable chemical or biological substance)through needles into the void. It may also be closed using mechanicalsutures or surgical staples, for example.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention, its nature, and various advantageswill be more apparent from the following detailed description and theaccompanying drawings, wherein like reference characters represent likeelements throughout, and in which:

FIG. 1 is a view of a surgical site in accordance with the principles ofthe present invention.

FIG. 2 is a detailed cut-away view of a portion of the surgical siteillustrated in FIG. 1.

FIG. 3 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 4 is a view similar to FIG. 3 showing a later stage in theillustrative procedure depicted in part by FIG. 3, together with relatedapparatus, all in accordance with this invention.

FIG. 5 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3 and 4, together with related apparatus, all inaccordance with this invention.

FIG. 6 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-5, together with related apparatus, all in accordancewith this invention.

FIG. 7 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-6, together with related apparatus, all in accordancewith this invention.

FIG. 8 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-7, together with related apparatus, all in accordancewith this invention.

FIG. 9 shows alternative related apparatus to that shown in FIG. 8 andshows an even later stage in the illustrative procedure depicted in partby FIGS. 3-7, together with related apparatus, all in accordance withthis invention.

FIG. 10 shows alternative related apparatus to that shown in FIGS. 8 and9 and shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-7, together with related apparatus, all in accordancewith this invention.

FIG. 11 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-10, together with related apparatus, all inaccordance with this invention.

FIG. 12 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-11, together with related apparatus, all inaccordance with this invention.

FIG. 13 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-12, together with related apparatus, all inaccordance with this invention.

FIG. 14 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-13, together with related apparatus, all inaccordance with this invention.

FIG. 15 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-14, together with related apparatus, all inaccordance with this invention.

FIG. 16 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-15, together with related apparatus, all inaccordance with this invention.

FIG. 17 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-16, together with related apparatus, all inaccordance with this invention.

FIG. 18 shows an even later stage in the illustrative procedure depictedin part by FIGS. 3-17, together with related apparatus, all inaccordance with this invention.

FIG. 19 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 19A is a perspective view of an illustrative embodiment ofapparatus in accordance with the principles of the present invention.

FIG. 20 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 21 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 22 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 23 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 24 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 25 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 26 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 27 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 28 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 29 is a view showing an illustrative procedure incorporating theapparatus of FIG. 28 in accordance with this invention.

FIG. 30 is a view similar to FIG. 29 showing a later stage in theillustrative procedure depicted in part by FIG. 29, together withrelated apparatus, all in accordance with this invention.

FIG. 31 shows an early stage in an illustrative procedure, together withrelated apparatus, all in accordance with this invention.

FIG. 32 is a view similar to FIG. 31 showing a later stage in theillustrative procedure depicted in part by FIG. 31, together withrelated apparatus, all in accordance with this invention.

FIG. 33 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 34 shows an early stage in an illustrative procedure, together withrelated apparatus, all in accordance with this invention.

FIG. 35 shows an early stage in an illustrative procedure, together withrelated apparatus, all in accordance with this invention.

FIG. 36 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 37 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 38 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 39 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 40 is a perspective view of an illustrative embodiment of apparatusin accordance with the principles of the present invention.

FIG. 41 is a view similar to FIG. 40 showing an earlier stage in anillustrative procedure depicted in part by FIG. 40, together withrelated apparatus, all in accordance with this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Because the present invention has a number of different applications,each of which may warrant some modifications of such parameters asinstrument size and shape, it is believed best to describe certainaspects of the invention with reference to relatively generic schematicdrawings. To keep the discussion from becoming too abstract, however,and as an aid to better comprehension and appreciation of the invention,references will frequently be made to specific uses of the invention.Most often these references will be to use of the invention to resectand replace or implant an aortic valve with an antegrade surgicalapproach. It is emphasized again, however, that this is only one of manypossible applications of the invention.

Assuming that the invention is to be used to resect and replace orimplant an aortic valve, the procedure may begin by setting upfluoroscopy equipment to enable the surgeon to set and use variousreference points during the procedure. The surgeon may begin byperforming a thoracotomy to create an access site for the surgicalprocedure. The endovascular, endocardiac or endoluminal surgical systemof the present invention incorporates accessing the interior of theheart by directly penetrating the heart muscle, preferably through theheart muscle at its left or right ventricular apex (hereinafter referredto as “transapically”). Thoracotomy sites may be prepared at any ofthird intercostal space 12, fourth intercostal space 14, fifthintercostal space 16, or subxyphoidal site 18 (i.e., just below xyphoidprocess 19) of patient 11, as shown in FIG. 1. Any intercostal space mayserve as a suitable surgical site, and in some embodiments of thepresent invention, the fourth, fifth, or sixth intercostal spaces arethe preferred sites. All of these sites provide surgical access to apex17 of heart 10. A 5-10 cm incision at any one of these sites may allowthe surgeon to perform the entire procedure through one access site.However, alternatively, the surgeon may prefer to use an endoscopictechnique wherein he or she may utilize 1-3 cm incisions at multiplesites to insert various instruments.

Once the heart is exposed, the surgeon may place one or multiplepurse-string sutures around the ventricular apex surgical site. Thiswill allow the surgeon to synch the heart muscle around any equipmentthat is passed through the heart wall during surgery to preventbleeding. Other techniques for preventing bleeding from the heartchamber that is accessed for surgery will be described in more detailbelow.

FIG. 2 illustrates the four chambers of heart 10; right atrium 24, leftatrium 25, left ventricle 26, and right ventricle 27. FIG. 2 also showsthe four valves of heart 10: aortic valve 20, mitral valve 21, pulmonaryvalve 22, and tricuspid valve 23. Ascending aorta 28 and descendingaorta 29 are also illustrated. A procedure to replace aortic valve 20may require a left thoracotomy and a left transapical incision to theheart muscle. Alternatively, a procedure to replace pulmonary valve 22may require a right thoracotomy and a right transapical incision to theheart muscle. Direct access may be made via incisions to right and leftatria 24 and 25 as well to enable antegrade approaches to tricuspidvalve 23 and mitral valve 21. While the procedure may be used forantegrade and retrograde repair to any of a patient's heart valves, thefollowing illustrative procedure relates to the resection and antegradereplacement of aortic valve 20. It should be understood that theresection steps may be skipped in the following procedure, and areplacement valve may alternatively be placed concentrically within thediseased valve.

In addition to the thoracotomy access site, the surgeon may also desireendoluminal (e.g., percutaneous) access sites, preferably via thepatient's femoral vein or artery. A femoral vein access site may be usedto place ultrasound equipment 34 inside the patient's right atriumadjacent aortic valve 20 and sino-tubular junction 36, as shown in FIG.3. Ultrasound equipment 34 may, for example, be an AcuNav™ DiagnosticUltrasound Catheter. Ultrasound equipment 34 could also be placed viathe internal jugular vein (IJV). Placement of ultrasound equipment 34via a femoral or iliac access site versus an IJV site may reverse theorientation of ultrasound equipment 34 (i.e., from which directionultrasound equipment 34 enters the patient's right atrium). As analternative to percutaneous ultrasound equipment, a surgeon may chooseto use esophageal visualization technology such as, for example,TransEsophageal Echo (“TEE”) to provide an image of the target valvereplacement site.

After accessing the heart muscle via one or more thoracotomies describedabove, an incision is made to pericardium 30 at access site 32. Next,myocardium 40 is punctured with needle 42 or other suitable device togain access to the inner heart structures (in this case, left ventricle26), as illustrated in FIG. 4. Guidewire 44 is fed into left ventricle26 in antegrade direction 46. Following the direction of blood flow,guidewire 44 is advanced through aortic valve 20 and into aorta 28.Guidewire 44 may be further advanced into the iliac or femoral arteries.In such embodiments, a wire with a snare loop may be advanced from thefemoral endoluminal access site to retrieve guidewire 44 and pull it outthe femoral endoluminal access site. This enables guidewire 44 to passthrough the patient's vasculature from transapical access site 17 to thefemoral endoluminal access site.

Guidewire 44 may be a relatively thin and flexible guidewire. In orderto provide sturdier support for the exchange of surgical tools, it maybe desirable to replace guidewire 44 with a stiffer guidewire. This isaccomplished by passing catheter 50 over guidewire 44, removingguidewire 44 from the patient while catheter 50 holds its place, andinserting a stiffer guidewire, as shown by FIG. 5. Once the stifferguidewire has been passed through catheter 50, catheter 50 can beremoved, leaving the stiffer guidewire in place. A guidewire that isexternalized from the patient at both ends (i.e., at the transapicalsite and the femoral endoluminal access site) would allow bi-directionaluse. Wire-guided devices could be inserted from both ends, allowing theinsertion of wire-guided devices from the antegrade and retrogradedirections.

In some embodiments of the present invention, multiple guidewires may beplaced to provide access for more surgical devices. Using multipleguidewires may provide advantages such as allowing two devices to beplaced next to each other (e.g., intravascular ultrasound could beoperated next to valve deployment devices). Multiple guidewires may beplaced simultaneously as shown in FIGS. 19 and 19A. Guidewire 198 is thealready placed initial guidewire (e.g., guidewire 66 of FIG. 6). Wireplacement device 190 or 195 glides over guidewire 198 via hollow opening191 or 197. Additional guidewires 192, 194, and 196 are attached to wireplacement device 190 such that all three additional wires are placed atone time. Additional guidewire 193 is attached to wire placement device195. Any number of guidewires can be attached to wire placement device190 or 195 so that the desired number of additional guidewires can besimultaneously placed. Wire placement device 190 or 195 may bebroken-off or cut away from the additional guidewires once they havebeen placed through the body. Also, wire placement devices 190 and 195may incorporate locking mechanisms. Thus, if the additional guidewiresare not to be passed all the way through the body such that they emergeat a second end, the wires can be clamped in place (e.g., wire placementdevices 190 and 195 may clamp to the initially placed guidewire to holdthe additional guidewires in place).

Next, a dilator (not shown) may be advanced over stiffer guidewire 66(FIG. 6) to dilate the opening created by needle 42 (FIG. 4) inmyocardium 40. Once the opening in myocardium 40 has been dilated to thenecessary size, access device 60 can be placed. Access device 60 willprovide an access port to the surgical site inside left ventricle 26,while preventing the heart chamber from bleeding out. Access device 60(shown in FIG. 6) allows for easy and rapid insertion of tools, devices,instruments, wires, catheters and delivery systems that will enable therepair or resection of a diseased heart valve or the implantation orreplacement of a new heart valve.

A second access device or introducer may be placed inside the distalartery (e.g., the femoral artery at the endoluminal access site).Furthermore, additional guidewires may be placed from the endoluminalaccess site. One or more additional guidewires may be placed using thepiggy-back approach described in more detail above.

Access device 60 may include catheter 64 with distal balloon 61 andproximal balloon 62. Balloons 61 and 62 may sandwich myocardium 40 toprevent bleeding from left ventricle 26. Access device 60 may beanchored in other suitable ways, as long as left ventricle 26 isappropriately sealed to prevent bleeding, and such that blood flowthrough the coronary arteries is not occluded. Access device 60 alsoincludes valve 63. Valve 63 allows the passage of guidewire 66 and theinsertion of surgical tools while preventing bleeding through catheter64. Valve 63 may be mechanically operable as an iris diaphragm (e.g.,like the aperture of a lens). Alternatively, valve 63 may be constructedof an elastic material with a small central opening that is dilated bywhatever equipment is inserted therethrough, but always maintains afluid-tight seal with the inserted equipment. Valve 63 may compose anyfluid-tight valve structure.

Access device 60 can include one or multiple valve-like structures, likevalve 63. Multiple valves in series may act as added protection againstleakage from the heart chamber. Furthermore, because of the potentialfor leakage around multiple tools, access device 60 may include multiplevalves in parallel. Thus, each tool could be inserted through its ownvalve. This could ensure that a proper seal is created around each toolbeing used during the operation.

In some embodiments of the present invention, various endovascular,endocardiac, and/or endoluminal visualization aids may be used. Suchdevices are illustrated in FIG. 7. Additionally, extracorporeal X-raybased radiographic devices may be employed. Preferably, intracardiacultrasound 34 is placed in the right atrium via a femoral vein, andintravascular ultrasound (IVUS) 70 is placed over guidewire 66 and intoa heart chamber or into the diseased valve. External fluoroscopy is alsoutilized to map and visualize the surgical site.

IVUS 70 may be used to locate aortic valve 20, sino-tubular junction 36,and brachiocephalic trunk 72. In order to determine the precise locationof each, IVUS probe 70's location is simultaneously tracked with AcuNav™34 and fluoroscopy. Once each landmark is located, a radioopaque markermay be placed on the patient's skin or the heart's surface so thatextracorporeal fluoroscopy can later be used to relocate these pointswithout IVUS 70 taking up space inside the surgical site. The end of thenative leaflet in systole may also be marked with a radioopaque markerin order to temporarily define the target zone. This technique requiresthat the patient and the fluoroscopy equipment not be moved during theprocedure, because landmarks inside the heart and aorta are being markedby radioopaque markers placed on the patient's skin outside the body oron the beating heart's surface. It may be desirable to place theradioopaque markers directly on the heart and aorta.

IVUS 70, AcuNav™ 34, and the fluoroscopy equipment can also be used totake measurements of the diseased valve. This allows the surgeon tochose a properly sized replacement heart valve. As an alternative tofluoroscopy, a surgeon may choose to use standard dye visualizationtechniques such as angiography. Although it would create materiallimitations for manufacturing the replacement heart valve, MRItechnology could be used as an alternative means of visualizing thetarget surgical site. Additionally, with the development of cameras thatcan see through blood, direct optical technology could be used to createan image of the target site. Real-time three-dimensional construction ofultrasound data is another visualization procedure that is currentlyunder development that could provide a suitable alternative.

With respect to direct optical technology, a clear liquid could beintroduced to the aorta or other components of the circulatory systemnear the target surgical site. Placing a clear liquid that is capable ofcarrying oxygen (i.e., capable of carrying on the blood's biologicalfunction, temporarily) in the patient's circulatory system would improvethe ability to use direct optical imaging. Furthermore, because theheart is beating, the patient could be transfused with the clearoxygen-carrying fluid for the duration of the procedure so that directoptical visualization is enabled throughout the procedure. The patient'sregular blood would be retransaused at the conclusion of the procedure.

Another option for a direct visualization technique includes placing atransparent balloon (filled with a transparent fluid such as water) infront of the camera. The camera and liquid-filled balloon are pushedagainst the surface that the surgeon wishes to view. The transparentballoon displaces blood from the camera's line of sight such that animage of what the camera sees through the balloon is transmitted to thesurgeon.

Furthermore, the invention may include the placement of embolicprotection device 80 in the ascending aorta by means of a catheter, asshown in FIG. 8. Embolic protection device 80 is preferably placed fromthe endoluminal femoral access site in a retrogade approach to theaortic valve site. Embolic protection device 80 may comprise a filteringmesh or net made from any suitable material. The chosen material shouldbe able to be collapsed, expanded, and re-collapsed multiple times.Embolic protection device 80 may alternatively be placed from theantegrade direction. Either approach may be made using guidewire 66 oradditional guidewires inserted in accordance with the present invention.

Single embolic protection device 80 may have unique properties toprotect the outflow region of the aortic valve which feeds aorta 28 andcoronary sinuses 82 and 84. Device 80 may comprise tight mesh 200 (seeFIG. 20) formed in a conical shape. Conical mesh 200 may terminate inperimeter 204 that exerts a radially outward force on the wall of aorta28. Device 80 is operated via catheter 202 and is dimensioned so that itis capable of filtering the blood supply to the aorta and the coronaryarteries.

In some embodiments, embolic protection device 80 may be replaced withmultiple embolic protection devices 90, 92, and 94, as illustrated inFIG. 9. In FIG. 9, each of coronary sinuses 82 and 84 is protected byits own embolic protection device (embolic protection devices 92 and 94,respectively), and aorta 28 is protected by embolic protection device90. Embolic protection devices 92 and 94 may be placed further into thecoronary arteries to keep the surgical site inside the aorta as clear aspossible. Embolic protection device 80 of FIG. 8 is designed so thatproper placement of the single protection device will prevent the flowof embolic material into any of aorta 28 and coronary sinuses 82 and 84.

In certain embodiments of the present invention, the embolic protectiondevice may be placed in an antegrade approach. For example, FIG. 10shows embolic protection devices 92′ and 94′ having been inserted in theantegrade direction. Placing devices 92′ and 94′ in the coronary sinusesfrom the antegrade direction leaves guidewires 101 and 102 to exit thepatient at the thoracotomy access site. Coronary sinuses 82 and 84provide useful landmarks in placing a new aortic valve. Thus, by placingdevices 92′ and 94′ in this manner, the surgeon is provided with a guideto proper placement of the new valve (i.e., guidewires 101 and 102 whichterminate at coronary sinuses 82 and 84). The new valve may be insertedin the antegrade direction along guidewires 101 and 102 to ensure properplacement.

Additionally, embolic filters may be placed in the brachiocephalic, leftcommon carotid, and left subclavian arteries of the aortic arch.

Some embodiments of the present invention may employ a valve-tippedcatheter or other temporary valve device that is capable of temporarilyreplacing the native valve function during and after resection orremoval until the new valve is deployed and functional. Such temporaryvalve devices may be placed in any number of acceptable locations. Forexample, when replacing the aortic valve's function, it may bepreferable to place the temporary valve in the ascending aorta justdistal to the native aortic valve. However, it is possible totemporarily replace the aortic valve function with a device placed inthe descending aorta. Such a placement may have the disadvantage ofcausing the heart to work harder, but such placements have been provenacceptable in previous surgical procedures.

Additionally, some embodiments of the present invention may include theuse of a percutaneously placed small caliber blood pump containing animpellor (e.g., a VAD (Ventricular Assist Device)). The VAD may beinserted in a retrograde or in an antegrade direction over guidewire 66.Alternatively, the VAD may be inserted over a secondary guidewire.Because of the resection and implantation equipment that will beinserted in the antegrade direction, it may be desirable to place theVAD in a retrograde approach from the percutaneous femoral access site.The VAD or other temporary pump device will be used to support theheart's natural function while the native valve is being resected orrepaired. The temporary assistance device will remain in place until thenew valve is deployed and functional.

FIG. 39 shows one possible combination of an embolic filter, temporaryvalve, and VAD. The FIG. 39 embodiment shows VAD 393 passing throughembolic filter 394 and temporary valve 395. These components arepositioned distal to aortic valve 392 in ascending aorta 396. Embolicfilter 394 is designed to also protect coronary arteries 390 and 391.Embolic filter 394, VAD 393, and temporary valve 395 may all be guidedby guidewire 397. This is just one possible arrangement for thecomponents that may be used in a valve repair or replacement procedure.

In some embodiments of the present invention, the placement of a newvalve may first involve the full or partial resection of the diseasedvalve or cardiac structure. To perform a resection of the diseasedvalve, a surgeon may use valve removal tool 110, shown in FIG. 11. Valveremoval tool 110 incorporates outer inflation lumen 111 and innerinflation lumen 112, which is placed coaxially within outer inflationlumen 111. Outer inflation lumen 111 terminates at proximal balloon 113.Inner inflation lumen 112 terminates at distal balloon 114. Coaxialcatheters 111 and 112 can be advanced over guidewire 66 and passedthrough valve 63 of access device 60. Radially expandable proximalcutting device 115 is mounted to the surface of distal balloon 113.Radially expandable distal cutting device 116 is mounted to the surfaceof distal balloon 114. Valve removal tool 110 is advanced with balloons113 and 114 in the deflated state and cutting devices 115 and 116 in thecollapsed state until distal cutting device 116 is located just distalto diseased aortic valve 20 and proximal cutting device 115 ispositioned just proximal to diseased aortic valve 20.

As shown in FIG. 12, balloons 313 and 114 are inflated such that cuttingdevices 115 and 116 are radially expanded to the approximate diameter ofthe diseased valve. Next, inner inflation lumen 112, distal balloon 114,and distal cutting device 116 are pulled in the retrograde direction.This causes cutting devices 115 and 116 to cooperate with one another tocut away diseased aortic valve leaflets 130, as shown in FIG. 13.Balloons 113 and 114 can be deflated and cutting devices 115 and 116collapsed while retaining cut away valve leaflets 130. Thus, valveremoval tool 110 and resected leaflets 130 can be removed via accessdevice 60.

Further, valve removal device 110 may possess self-centering properties.Valve removal device 110's cutting mechanism may allow the device to cutor resect any calcified or diseased tissue within the heart cavities orthe vasculature. The size or cut of each bite made by the removaldevice, as well as the shape of the cut may be determined by the surgeonby adjusting the valve removal device.

When performing surgical techniques inside a patient's vasculature, itmay be beneficial to use ring-shaped balloons so that blood can continueto circulate through the balloon. Also, whether using ring-shapedballoons or more standardized balloons, it may be beneficial to use aballoon that has more than one chamber, so that the balloon can beselectively inflated. Examples of a ring-shaped balloon and acylindrical balloon, both having more than one inflation chamber areillustrated in FIGS. 37 and 38, respectively.

FIG. 37 shows ring-shaped balloon 370. Balloon 370 may be divided intothree inflation chambers by dividers 373′, 373″, and 373′″, eachinflation chamber may be attached to an inflation flange (e.g., flanges374′, 374″, and 374′″). Each inflation flange is correspondinglyattached to an inflation lumen of catheter 371 (e.g., inflation lumens372′, 372″, and 372′″). Thus, blood flow is able to continue through thethree openings left between inflation flanges 374′, 374″, and 374′″.Furthermore, surgical tools (e.g., VADs, etc.) may be passed through theopenings. Balloon 370 may be guided by guidewire 375.

FIG. 38 shows cylindrical balloon 380 with inflation chambers 381, 382,and 383. The inflation chambers may be selectively inflated by inflationlumens 384, 385, and 386, respectively of catheter 387. Balloon 380 maybe guided by guidewire 388. By providing selectively inflatable chambersin either type of balloon, a surgeon may have the ability to manipulatetissue inside a patient's vasculature or properly position surgicalequipment and prostheses, for example.

In some embodiments of the present invention, a valve removal tool suchas ronjeur device 210 may be used (see FIG. 21). Ronjeur device 210 mayhave spoon-shaped heads 212 and 214 which are operably controlled byhandles 216 and 218 via hinge 211. Spoon-shaped heads 212 and 214 mayhave sharpened tips 213 and 215, respectively. Ronjeur device 210 may beused to bite away the leaflets of a diseased valve and trap, thedissected tissue within spoon-shaped heads 212 and 214. Ronjeur device210 may be operable via access device 60.

In other embodiments of the present invention, valve resector 220 ofFIG. 22 can be used to resect the diseased valve. Valve resector 220 hashandle 222, shaft 224, recess 226, and resector tip 228. Resector tip228 may be used to cut away or tear away the diseased leaflets of anative valve. Recess 226 may be used to retain the resected tissue forremoval. Resector tip 228 may also be mechanically operable to snip awaythe diseased leaflets. Resector 220 is also operable via access device60. Other suitable techniques for resecting a diseased valve may also beused before implanting a new valve.

In preparation for valve resection, it may be beneficial to soften orbreak-up the calcification of the diseased valve. Concentratedultrasound waves could be used to break-up the valve's calcification. Asimilar procedure is used to break down kidney stones in some patients.Calcification of the aortic valve is often trapped in tissue pockets.Thus the broken-down calcification would likely be retained by the valveleaflets. However, the leaflets would now be more pliable and easier tocompress behind a new valve or to remove. An intraluminal ultrasounddevice may be used to deliver the concentrated ultrasound waves.Furthermore, an intraluminal reflector may be used to magnify the waves'intensity and break-up the calcium deposits even quicker.

In addition to or as an alternative to resecting the diseased valve,plaque or calcification of a diseased valve may be chemically dissolved.With embolic protection devices 90, 92, and 94 in place, a chemical canbe introduced to the diseased valve that will dissolve or release theplaque deposits. The target valve site may first be isolated to containthe chemical during this process. This isolation may be achieved byinflating two balloons to create a chemical ablation chamber defined bythe wall of the aorta and the two balloons.

Isolation may also be achieved by a device like ablation chamber 360shown in FIG. 36. Ablation chamber 360 is positioned inside thepatient's vasculature (e.g., aorta 362). The chamber may be placedpercutaneously, by direct access, or by any other suitable technique.Ablation chamber 360 comprises ring-shaped balloons 361 and 363.Balloons 361 and 363 are joined by tubular member 367 which creates achannel for blood to by-pass the ablation site. A ventricular assistdevice may be inserted through opening 365 in tubular member 367 to aidthe patient's blood flow through the temporarily narrowed passageway.Ablation chamber 360 may include chemical introducer 364 and chemicalevacuator 366 to introduce a chemical to the ablation site and to clearthe chemical from the ablation site when the procedure is completed.Thus, the chemical ablation procedure is performed in the chamber of theisolated segment of the aorta while normal circulatory function takesplace. Such a technique isolates the chemical being used from enteringthe patient's circulatory system. This treatment may be performed torepair a diseased valve, to decalcify a diseased valve before resectionby a valve removal tool, or to decalcify a diseased valve before placinga new valve within and over top of the diseased valve. Laser ablationmay also be used to break up valve calcification or to remove anddestroy diseased valve leaflets.

As another alternative, the diseased and calcified valve can be left asis and a new valve can be implanted within and over top of the diseasedvalve. In some embodiments of the present invention, it may be desirableto perform a valvuloplasty to percutaneously destroy the leaflets of thediseased valve. It may be easier to dilate the diseased valve with thenew valve if it has been partially destroyed first.

Once any manipulation of the diseased valve is complete (e.g., markinglandmark locations, resecting the diseased leaflets, chemicallydissolving calcification, etc.), embolic protection devices 90, 92, and94 can be removed (FIG. 14). The resection of diseased leaflets 130(FIG. 13) may leave behind valve rim 141 (FIG. 14). Once the embolicprotection devices have been removed, valve delivery device 142 may beinserted into left ventricle 26 via access device 60. Valve deliverydevice 142 carries new valve 140 in a radially compressed state. Valve140 has been crimped onto delivery device 142. Alternatively, valve 140may be folded or collapsed in any other suitable manner. Valve deliverydevice 142 is advanced along guidewire 66.

In embodiments like that shown in FIG. 10, valve delivery device 142 mayalso be guided by guidewire 101 and 102 to ensure safe orientation ofvalve 140 prior to release and deployment. Such a delivery approachwould eliminate the danger of coronary obstruction, because guidewires101 and 102 terminate at coronary sinuses 82 and 84. The spaces betweenthe commissure supports of valve 140 could be properly aligned withcoronary sinuses 82 and 84 to allow maximum blood flow to the coronaryarteries.

In other embodiments of the present invention, the placement of valve140 may be assisted by intracardiac ultrasound (i.e., ultrasoundequipment 34 of FIG. 7) and fluoroscopy. Positioning, release, anddeployment of valve 140 could be simultaneously monitored by theintracardiac ultrasound and fluoroscopy equipment. The fluoroscopyequipment would monitor the target zone based on the radioopaque markersthat were placed earlier in the procedure. When the fluoroscopic (markerposition) and sonographic (intracardiac ultrasound) target sites arecongruent, the proper position for valve deployment has been located. Atthat moment, valve 140 may be deployed as described below.

Additionally, valve delivery device 142 may contain two radioopaquemarkers. With the coronaries being visualized with fluoroscopy, thesurgeon could visualize the alignment of the two marker bands ondelivery device 142. Thus, the surgeon would be able to properly orientthe valve such that the commiseure posts are properly positioned uponvalve deployment.

Valve delivery device 142 may terminate in two phase balloon 150, asshown in FIG. 15. Alternatively, the end of device 142 carrying valve140 may have two separately operable balloons. The first phase ofballoon 150 may be inflated to provide a positioning guide for valve140. The first phase of balloon 150 provides a bumper such that deliverydevice 142 is prevented from further advancement when the proximal endof balloon 150 (i.e., the first phase of balloon 150) reaches the regionof left ventricle 26 just proximal to the aortic valve site.

Continued expansion of balloon 150 causes base ring 154 of valve 140 toexpand. As base ring 154 expands, hooks 156 may bite into remainingaortic rim 141. Alternatively, hooks 156 may not penetrate rim 141, butrather grasp the rim tightly. Commissure support tissue 158 also beginsto open up. In some embodiments of the present invention, valve 140includes distal stent-like structure 152 to support a replacement aorticvalve distal to coronary sinuses 82 and 84 in sino-tubular junction 36.

During expansion, intracardiac ultrasound and fluoroscopy can be used tomonitor the orientation and placement of valve 140. Before valve 140 isfully expanded, the surgeon may rotate delivery device 142 such that thespaces between commissure supports 158 align with coronary sinuses 82and 84. Upon full expansion of ring 154 (see FIG. 16), hooks 156 mayfully engage rim 141, and hooks 156 and rim 141 may be partiallyembedded in aortic wall 151. Stent-like structure 152 may engage aorticwall 151 in sino-tubular junction region 36. Commissure supports 158will be fully expanded, too. Support structure 152 may expand in unisonwith base ring 154. Alternatively, valve placement may take place in astepped process, wherein base ring 154 expands and secures the base ofthe valve before support structure 152 expands to secure the distal endof the valve. The location and function of new valve 140 are identifiedand monitored with IVUS, intracardiac ultrasound, and/or fluoroscopy.Once placement and function is satisfactory to the surgeon, balloon 150is deflated, and valve delivery device 142 is removed from leftventricle 26.

The implantation process should be done quickly, because there will be abrief total occlusion of the aorta. It may be desirable to block theinflow to the heart. Thus, the heart is not straining to pump blood out,and a dangerous lowering of the patient's heart rate may be prevented.

Valve delivery device 142 may be designed to draw the native leafletsdownward when a new valve is being implanted over top of an existingdiseased valve. The native leaflets could obstruct blood flow to thecoronary arteries. However, pulling the native leaflets downward beforecompressing them against the aorta wall would prevent such occlusion.

In some embodiments of the present invention, new valve 140 may be aself-expanding valve that can be implanted without the use of a balloon.Base ring 154, hooks 156, and stent-like structure 152 may beconstructed of nitinol or some other shape-memory or self-expandingmaterial. In some embodiments, valve 140 may be deployed by mechanicalmeans, such as by releasing a lasso that surrounds the exterior of valve140 or by operating a mechanical expansion device within valve 140.

In certain embodiments of the present invention, valve 140 may not havea stent-like support structure at the distal end (i.e., stent-likestructure 152). If commissure supports 158 are constructed from orsupported by a stiff enough support post, valve 140 may not be fixed tothe aorta at its distal end. The mounting at base ring 154 maysufficiently secure valve 140 in place to function normally and notobstruct blood flow to the coronary arteries.

Valve 140 may be secured in place by any suitable method for anchoringtissue within the body. The radial expansion forces of base ring 154 maybe strong enough to secure valve 140 against dislodgment by radialstrength alone. If no native valve rim remains, hooks 156 may bedesigned to grasp aortic wall 151. Mechanically placed sutures orstaples could be used to secure valve 140 in place. Furthermore,biocompatible glue could be used to secure valve 140 in the appropriateposition.

During a valve implantation procedure, it may be desirable to have theability to retract expansion of new valve 140. If the commissures arenot properly aligned with the coronary arteries or if the valve is notproperly positioned within the native annulus, retracting the expansionwould enable repositioning or realignment of the valve. Such aretraction technique is illustrated in FIG. 23 wherein valve 230 is oneillustration of a possible embodiment of valve 140.

Valve 230 has radially expandable support ring 232 and radiallyexpandable mounting structure 231. Mounting structure 231 may be asinusoidal ring of nitinol wire. Mounting structure 231 is attached towires 237, 238, and 239 at points 234, 235, and 236, respectively. Byadvancing tube 233 or withdrawing wires 237, 238, and 239, mountingstructure 231 may be drawn radially inward, effectively retracting theexpansion of valve 230. Other means of retracting valve expansion couldbe employed in accordance with the principles of the present invention.

In some embodiments of the present invention, the dilated opening inmyocardium 40 is sealed with an automatic closure device. The automaticclosure device may be part of access device 60. Alternatively, theautomatic closure device may be inserted through access device 60 suchthat removal of access device 60 leaves the automatic closure devicebehind.

For example, FIG. 17 shows automatic closure device 172 being deliveredwith closure delivery device 170. Closure device 172 may includeproximal umbrella 174, distal umbrella 178, and connecting shaft 176therebetween. Delivery rod 171 may be used to advance proximal umbrella174 from delivery device 170 such that umbrella 174 opens. Balloons 61and 62 of access device 60 are deflated. Then, both access device 60 anddelivery device 170 are withdrawn from heart 10. Umbrella 174 willcontact the inner surface of myocardium 40, as shown in FIG. 18. Uponfurther withdrawal of access device 60 and delivery device 170, distalumbrella 178 will be permitted to deploy. Upon deployment of umbrella178, the hole formed in myocardium 40 will be sealed. Myocardium 40 maybe sealed using any acceptable automatic closure device. Alternatively,myocardium 40 may be sutured closed. Additionally, myocardium 40 may beclosed with any known closure device, such as an Amplatzer™ occlusiondevice, other double-button device, plug, or laser plug.

Bleeding into the space between the myocardium and the pericardiumshould be prevented. The myocardium can be closed without a need toclose the pericardium. However, if the pericardium is to be sealed withthe automatic closure device, the seal must be tight enough to preventbleeding into the void between the two.

The percutaneous femoral access site will also need to be sealed. Thismay be done with sutures, or with a self-closing device such as anAngioseal™ Hemostatic Puncture Closure Device.

Implantable valves in accordance with the preferred embodiments of thepresent invention may take on a number of forms. However, theimplantable valves will likely exhibit several beneficialcharacteristics. Implantable valves should preferably be constructed ofas little material as possible, and should be easily collapsible. Thevalve may be radially compressed to a size significantly smaller thanits deployed diameter for delivery. The implantable valve or supportelements of the valve may contain Gothic arch-type structural supportelements to efficiently support and maintain the valve once it isimplanted.

The implantable valve may have an outer stent that is installed beforedeploying the valve structure. Valves manufactured in accordance withthe principles of the present invention are preferably constructed ofbiocompatible materials. Some of the materials may be bioabsorbable, sothat shortly after the implantation procedure, only the anchoring deviceand tissue valve remain permanently implanted. The valve leaflets may becomposed of homograph valve tissue, animal tissue, valve rebuildmaterial, pericardium, synthetics, or alloys, such as a thin nitinolmesh.

Implantable valves in accordance with the principles of the presentinvention may be drug eluding to prevent restenosis by inhibitingcellular division or by preventing reapposition of calcium. The drug mayact as an active barrier that prevents the formation of calcium on thevalve. Additionally, the drug may stimulate healing of the new valvewith the aorta. Furthermore, the implantable valves are preferablytreated to resist calcification. The support elements of the implantablevalve may be exterior to the valve (e.g., between the new valve tissueand the aorta wall), interior to the valve (e.g., valve tissue isbetween the support elements and the aorta wall), or may form anendoskeleton of the valve (e.g., support elements of the valve may bewithin the tissue of the implantable valve).

FIGS. 24-26 illustrate new valves that could be used for replacement orimplantation procedures in accordance with the principles of the presentinvention. Valve 240 of FIG. 24 has sinusoidal attachment member 241encircling the base of commissure posts 242, 243, and 244. Attachmentmember 241 may be any radially compressible and expandable member.Member 241 of FIG. 24 has proximal peaks 245 and distal peaks 246 whichmay be turned outward. Peaks 245 and 246 may be better suited to engagethe wall of the aorta when the peaks are turned outward. Peaks 245 and246 may also be pointed or sharpened so that they penetrate the aortawall. In embodiments in which a small rim of native valve has been leftbehind after resection, peaks 245 and 246 may be biased to closeoutwardly, effectively biting the rim of remaining tissue. Commissureposts 242, 243, and 244 and the valve's leaflets (not shown) fold andcollapse when member 241 is radially compressed for delivery.

Valve 240 may have distal mounting ring 248 in some embodiments. Ring248 may engage the distal portion of the sino-tubular junction. Ring 248may have segments 249 that are biased radially outward so as to moresecurely engage the inner wall of the aorta. The replacement valve maybe designed to mimic the natural curvature of the sino-tubular junction.This curvature creates a natural bulge, in which the replacement valvemay be able to secure itself against dislodgement.

Valve 250 of FIG. 25 shows tissue 252 inside stent frame 254. Tissue252, which forms the leaflets of the implantable valve may be engineeredand/or grown directly inside of stent frame 254. Alternatively, tissue252 may be glued or sutured to stent frame 254, Stent frame 252 mayincorporate peaks that are turned outward that may have pointed orsharpened tips like those described with respect to valve 240 of FIG.24. Also, ring 256 may have hook features such as hooks 156 of FIG. 15.Stent frame 252 may be constructed from a shape memory or otherself-expanding material. Alternatively, stent frame 252 may beconstructed from stainless steel or other materials that are balloonexpanded or mechanically expanded.

Valve 260 of FIG. 26 illustrates one embodiment of a low profile valve.Such a low profile valve may reduce the likelihood of coronary arteryobstruction. Valve 260 may comprise any number of leaflets. Valve 260 isillustratively shown with five leaflets (i.e., leaflets 261, 262, 263,264 and 265). The leaflets overlap one another in a domino-typearrangement. Leaflet 265 is the top-most leaflet, overlapping the leftside of leaflet 264. The right side of leaflet 264 overlaps the leftside of leaflet 263, and so on with leaflet 261 being the bottom-mostleaflet. The leaflets may be arranged such that they overlap one anotherin a clockwise or a counterclockwise fashion. Valve 260 may appear toopen like the iris of a camera when viewed from the top (as shown inFIG. 26). The leaflets actually rise out of the plane of the valveannulus. However, because of the valve's very low profile, no commissuresupports are needed.

Additionally, spiral, or rolled valves may be used in the implantationor replacement procedure. Such valves unwind instead of being radiallyexpanded. Rolled valves are reduced in diameter for percutaneous orminimally invasive implantation by rolling the valve material into aspiral.

It may be beneficial to replace an insufficient valve with a new valvethat is designed so that it does not dilate to the size of the diseasedvalve. Insufficient valves do not fully close, permitting regurgitationin the blood flow. This is often the result of a dilated valve annulus,which does not allow the valve leaflets to come together in the center.Therefore, it may be desirable for the new valve to fill a smallerannulus. This can be achieved by designing a valve such as valve 270 ofFIG. 27. Valve 270 has fluid-tight membrane 276. Thus, while supportstructure 272 dilates to the diameter of the diseased valve's annulus,leaflets 274 of the replacement valve operate in an annulus of fixedsize determined by membrane 276.

In some embodiments of the present invention, the new valve may bedesigned to be exchangeable. Many replacement heart valves have a lifeexpectancy of 10-20 years. Therefore, many patients will requirefollow-up valve replacements. Certain structural components of the heartvalve (e.g., the base ring, hooks, etc.) could be permanent, while thetissue leaflets may be exchangeable. It may be preferable to simplydilate the old valve with the new valve.

In some embodiments of the present invention, a valve implantationprocedure may take place “off-pump,” but the patient's heart may betemporarily arrested. The patient's heart is stopped using fibrillation.A surgeon will have just under three minutes to perform the surgicalprocedure without risking harm to the patient. However, the anesthetizedpatient could be cooled to provide the surgeon with more time withoutincreasing the risk for brain damage.

Once the patient's heart is stopped, an incision is made to the aortajust distal to the aortic valve. Blood is cleared from this region sothat the surgeon can visualize the valve site. Using a delivery devicelike that described above (except making a retrograde approach in thiscase), the new valve is implanted directly over the diseased valve.Because the valve is being installed in a retrograde approach, thenative leaflets will be pushed downward before being compressed againstthe aorta wall. Therefore, there is no concern of coronary arteryocclusion.

Once the new valve is installed, the surgical site inside the aorta iscleared of air, and a side bite clamp is placed on the lesion. The heartis restarted with the electrodes that were used to stop it previously.Once the heart is beating again, the clamped lesion is sutured closed.An introducer device (similar to access device 60) can be used at theincision site to prevent the need for clearing the blood from thesurgical site and later deairing the site.

There are numerous procedures that may be performed transapically inaccordance with the principles of the present invention. The followingdescribes several of the illustrative procedures that may be performedvia a transapical access device.

Insufficient mitral valves often result from a dilated posteriorleaflet. FIGS. 28-30 demonstrate a tool that could be used to repair aninsufficient mitral valve via a transapical access device. Repair tool280 may have U-shaped head 282 and single-pronged head 284. Heads 282and 284 may be operably attached by hinge 288. When posterior leaflet290 (FIG. 29) is inserted between heads 282 and 284, handles 283 and 285can be squeezed together to cause a portion of posterior leaflet 290 tobe drawn downward. At this point, attachment tool 286 can deployconnector 300 (FIG. 30) to retain posterior leaflet 290 in a constrainedstate, repairing any excess dilation of the mitral annulus. Connector300 may be a surgical staple, mechanical suture, or other suitableconnector.

Aortic dissection is another defect that may be repaired via transapicalaccess to the heart. Aortic dissection occurs from a tear or damage tothe inner wall of the aorta. Aortic dissection may be caused bytraumatic injury or connective tissue diseases such as Marfan syndromeor Ehlers-Danlos syndrome, for example. Aortic dissection may result inatherosclerosis or high blood pressure. As shown in FIG. 31, aorticdissection 318 may result in void 319.

Aortic dissection repair device 310 may be transapically inserted into apatient via access device 311 (substantially similar to access device 60of FIG. 6). Repair device 310 may include balloon 312 and catheter 314and may be guided by guidewire 316. Though not shown, catheter 314 mayinclude several lumens (e.g., a balloon inflation lumen, a guidewirelumen, and a glue delivery lumen).

Once repair device 310 is properly located, balloon 312 may be inflatedas shown in FIG. 32. The inflation of balloon 312 may cause needles 320to penetrate aortic dissection 318 such that the tips of needles 320 areexposed to void 319. A biologically compatible glue may be injectedthrough needles 320 via the glue delivery lumen (not shown) of catheter314. Further inflation of balloon 312 may ensure that dissection 318 issecurely affixed to the aorta wall by the biologically compatible glue.

In order to make sure that the biologically compatible glue is onlyinjected into void 319, and not the remainder of the aorta (which mayintroduce the biologically compatible glue to the circulatory system),dye may first be injected through select channels (i.e., needles 320).This will allow a surgeon to determine if injected glue would only endup in the desired locations. Repair device 310 may then be rotated toalign the needles that will inject the biologically compatible glue withvoid 319. Alternatively, the needles that will be used to inject theglue may be selectable so that the surgeon activates only the needlesaligned with void 319.

Because balloon 312 fully occludes the aorta, balloon 312 may bedoughnut-shaped to allow blood to pass, like balloon 330 of FIG. 33.Additionally, balloon 330 may include VAD device 332 to pump blood fromthe proximal side of balloon 330 (at inlet ports 334) to the distal sideof balloon 330 (at outlet ports 336). The repair device may stillinclude needles 338. The aortic dissection repair procedure may bemonitored with any of the visualization equipment discussed in moredetail above. Once the aortic dissection has been repaired, balloon 312or 330 may be deflated, and repair device 310 is removed from thepatient.

Left ventricular aneurysms are another deformity of the heart that maybe treated transapically. The heart muscle in the area of a blood vesselblockage can die over time. The healing process may form a scar thatcould thin and stretch to form a ventricular aneurysm. Such aneurysmsmay be repaired as described below.

Left ventricular aneurysm 340 may form in left ventricle 341 of apatient, as shown in FIG. 34. Because aneurysm 340 can cause the heartto work harder over time and result in eventual heart failure, theaneurysm should be treated. Aneurysm repair device 336 may be insertedthrough access device 344 (substantially like access device 60 of FIG.6). Repair device 346 may include liquid filled bolster 342 that ismounted inside left ventricular aneurysm 340. Bolster 342 may be mountedwith a biologically compatible glue, by mechanical means, or by anyother suitable mounting technique.

In some embodiments of the present invention, aneurysm 340 may berepaired by pulling the ends of aneurysm 340 together, as depicted byFIG. 35. In such embodiments, aneurysm repair device 350 may be used todeploy hooks 352 and 354. Hooks 352 and 354 may grasp the interior ofthe heart at the extremes of the aneurysm and then draw the aneurysmclosed. Once the aneurysm has been drawn together, any suitabletechnique can be used to secure the aneurysm in the closed position(e.g., biologically compatible glue, surgical staples, mechanicallyplaced sutures, etc.) Once the aneurysm has been fully sealed, repairdevice 350 may be withdrawn from the patient.

In some embodiments of the present invention, endoprostheses may beplaced percutaneously, transapically, or via any combination of surgicalapproaches. Endoprostheses may be placed in the ascending aorta thathave arms capable of extending into the coronary arteries.Endoprostheses for the ascending aorta could also include a replacementvalve or a valved stent. Endoprostheses for the descending aorta couldalso be placed transapically or percutaneously, for example, to repairan abdominal aortic aneurysm.

Additionally, endoprostheses may be placed in the aortic arch. Oneembodiment of an endoprosthesis for the aortic arch is shown in FIG. 40.Endoprosthesis 402 may be placed in aortic arch 400. Furthermore,endoprosthesis 402 may include arms 403, 405, and 407 that extend intobrachiocephalic artery 404, left common carotid artery 406, and leftsubclavian artery 408, respectively.

Endoprosthesis 402 may be placed using guidewires 410, 412, 414, and416, as shown in FIG. 41. Guidewire 410 may pass through the body ofendoprosthesis 402, while guidewires 412, 414, and 416 may pass throughholes 403′, 405′, and 407′ of the ends of arms 403, 405, and 407,respectively. Once endoprosthesis 402 is properly positioned in aorticarch 400, arms 403, 405, and 407 may be extended to a positionsubstantially perpendicular to the body of endoprostheses 402. In orderto aid the insertion of the arms of endoprosthesis 402 into therespective arterial branches, small catheters, or other pushing devices,may be inserted over guidewires 412, 414, and 416 to manipulate (e.g.,push) the arms of the endoprosthesis. The arms and body ofendoprosthesis 402 may be radially expanded once the endoprosthesis isproperly positioned.

Currently, ventricular arrhythmias are percutaneously repaired withradio frequency, cold, heat, or microwave that is applied to theoffending tissue to destroy the source of the arrhythmia. Ventriculararrhythmias could be repaired transapically in accordance with theprinciples of the present invention. Radio frequency, cold, heat, ormicrowave devices can be introduced through an access device like accessdevice 60 of FIG. 6.

Hypertrophic obstructions (i.e., obstructions distal to a heart valve)and subvalvular stenosis (i.e., an obstruction proximal to a heartvalve) may also be treated transapically. Devices such as thosedescribed above to resect a diseased valve could be insertedtransapically to cut away the hypertrophic or subvalvular obstruction.The extra tissue could be removed from the heart in the same way thatthe diseased valve is resected and removed.

Robotic technology similar to that currently used in operating roomscould be used to perform some of the steps of the heart valve removaland replacement or implantation procedure. For example, it may bedesirable to have a robot perform the delicate resection procedure viathe access device. Furthermore, a robot could exercise precision inrotating and positioning the replacement valve with proper alignment ofthe commissure posts.

Because the heart valve operation is being performed inside one or moreof the heart's chambers, all of the equipment described above should beatraumatic to limit damage to the endothelial wall of the heart.

It will be understood that the foregoing is only illustrative of theprinciples of the invention, and that various modifications can be madeby those skilled in the art without departing from the scope and spiritof the invention. For example, the order of some steps in the proceduresthat have been described are not critical and can be changed if desired.Also, various steps may be performed with various techniques. Forexample, the diseased valve may be removed transapically, while thereplacement valve is implanted percutaneously, or vice versa. The mannerin which visualization equipment and techniques are used for observationof the apparatus inside the patient may vary. Many surgical repairprocedures can be performed on or near the heart in accordance with theprinciples of the present invention.

1-45. (canceled)
 46. A heart valve having a longitudinal axis, the valvecomprising a self-expanding stent that includes a curved tissue-engagingpeak that curves away from the longitudinal axis.
 47. The valve of claim46 wherein the self-expanding stent defines: a first circumference in afirst plane perpendicular to the longitudinal axis; a secondcircumference in a second plane perpendicular to the longitudinal axis;and a third circumference in a third plane perpendicular to thelongitudinal axis; wherein: the second circumference is between thefirst and third circumferences; the first and third circumferences aregreater than the second circumference; and the tissue-engaging peak ispart of the third circumference.
 48. The valve of claim 47 wherein thefirst, second and third circumferences, together, are configured toconform to a native valve rim to secure the valve against dislodgementfrom the native valve rim.
 49. The valve of claim 47 further comprisinga securement element that is supported by the self-expanding stent, thesecurement element providing security against dislodgement, from hearttissue, of the self-expanding stent.
 50. The valve of claim 49 whereinthe securement element is a hook.
 51. The valve of claim 49 wherein thesecurement element is configured to bite into an aortic rim.
 52. Thevalve of claim 49 wherein the securement element is configured to biteinto an aortic wall.
 53. The valve of claim 49 wherein the securementelement is configured to grasp an aortic rim.
 54. The valve of claim 49wherein the securement element is configured to grasp an aortic wall.55. The valve of claim 46 wherein the self-expanding stent includes asinusoidal structure.
 56. The valve of claim 46 wherein theself-expanding stent is configured to exert radial expansion forces thatare strong enough to secure the valve against dislodgment.
 57. The valveof claim 46 wherein the peak is included in a plurality of peaks, theplurality including proximal peaks and distal peaks.
 58. The valve ofclaim 57 wherein the proximal peaks and distal peaks are configured toengage a native valve annulus.
 59. The valve of claim 58 wherein theproximal peaks and the distal peaks are pointed or sharpened.
 60. Thevalve of claim 46 wherein the peak is a distal peak and is configured toengage an aortic wall.
 61. The valve of claim 46 further comprising adistal mounting ring supported distal to the peak by distal ends ofcommissure supports, the distal mounting ring corresponding to an aorticwall extending from an aortic sino-tubular junction.
 62. The valve ofclaim 46 further comprising a stent-like support structure supporteddistal to the peak by distal ends of commissure supports andcorresponding to an aortic wall extending from an aortic sino-tubularjunction.
 63. The valve of claim 62 wherein the stent-like supportstructure is configured to support a distal end of the valve such thatthe valve is supported against the aortic wall at a location distal tocoronary sinuses.
 64. The valve of claim 46 wherein the self-expandingstent includes a bulge that corresponds to a natural curvature below anaortic sino-tubular junction, the bulge providing securement againstdislodgement of the valve relative to the curvature.
 65. The valve ofclaim 64 wherein the bulge mimics the natural curvature.
 66. The valveof claim 64 further comprising a commissure support that has a portionthat is included in the bulge.
 67. The valve of claim 46 furthercomprising valve leaflets, wherein the stent includes a stent frame thatincludes commissure supports configured to support the valve leaflets.68. The valve of claim 46 further comprising attachment pointsdesignated for attachment to corresponding retraction devices.
 69. Thevalve of claim 68 wherein the attachment points are designated forattachment to corresponding retraction wires.
 70. The valve of claim 46wherein the self-expanding stent is configured to be mechanicallyattached to a delivery device.
 71. The valve of claim 46 wherein theself-expanding stent is compressible.
 72. The valve of claim 46 furthercomprising commissure supports that are configured to support, distal tothe peak, valve leaflets.
 73. The valve of claim 46 wherein theself-expanding stent comprises a shape-memory material.
 74. The valve ofclaim 46 wherein the peak is a proximal peak and is configured to engagea native valve annulus.
 75. The valve of claim 46 wherein the peak isincluded in a plurality of peaks, the plurality including proximalpeaks.
 76. The valve of claim 46 wherein the peak is included in aplurality of peaks, the plurality including distal peaks.
 77. The valveof claim 47 wherein the second and third circumferences, together, areconfigured to conform to a native valve rim to secure the valve againstdislodgement from the native valve rim.
 78. The valve of claim 77wherein the first circumference is configured to be deployed distal toan aortic sino-tubular junction.
 79. The valve of claim 77 wherein thefirst circumference is configured to be deployed at an aorticsino-tubular junction.
 80. The valve of claim 47 wherein the thirdcircumference is configured to conform to a native valve rim to securethe valve against dislodgement from the native valve rim.
 81. The valveof claim 80 wherein the first circumference is configured to be deployeddistal to an aortic sino-tubular junction.
 82. The valve of claim 80wherein the first circumference is configured to be deployed at anaortic sino-tubular junction.
 83. The valve of claim 64 wherein thebulge is configured to conform to the natural curvature.